tbuckley/cabot-search huggingface dataset:
Risk factors of early liver metastasis in patients with breast cancer.
Authors: Minxue Zhu, Sujin Yang
Journal: Journal of Clinical Oncology (2023)

e13011 Background: Breast Cancer Liver Metastasis is very common in the clinical treatment of breast cancer. Although great progress has been made in the early diagnosis and treatment of breast cancer, 20% to 30% of patients with early breast cancer will develop tumor metastasis. Relevant studies have found that liver metastasis is an independent predictor of poor overall survival in breast cancer patients compared with bone metastasis and other factors. There is a lack of large-scale clinical research on the risk factors of early liver metastasis of breast cancer across the world. This study aims to explore the possible risk factors of early liver metastasis of breast cancer patients by analyzing the clinical data of 70 breast cancer patients with first liver metastasis. Methods: A retrospective study was conducted on 70 female breast cancer patients with liver metastasis who were diagnosed and treated in the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2021 and had complete medical records. The main clinical and pathological data of the patients were obtained by reading the medical records, such as age, menstrual status, surgical method, history of non-alcoholic fatty liver disease, T stage of the primary tumor, molecular type, vascular tumor thrombus and pathological type. SPSS 25.0 statistical software was used to analyze the data. Kaplan-Meier Survival curve and log-rank test were used to compare the disease-free survival (DFS) of breast cancer patients with and without non-alcoholic fatty liver Disease, different ER expression, Ki67 expression and histological grade. DFS is the interval between breast cancer surgery and the occurrence of metastases. COX regression model was used to analyze the risk factors of early metastasis of breast cancer. P &lt; 0.05 was considered statistically significant. Results: The median liver metastasis-free time of the 70 breast cancer patients was 34 months (range 4-121 months). High histological grade, non-alcoholic fatty liver disease, negative expression of ER and Ki-67&gt;15% were risk factors for early liver metastasis in patients with breast cancer after operation (χ2 =8.367, P=0.015; χ2 =6.883, P=0.009; χ2 =7.507, P=0.006; χ2 =10.488, P=0.001). Conclusions: In this study, the independent risk factors of early liver metastasis in breast cancer patients are high histological grade, high expression of Ki-67, and combined with alcoholic fatty liver, which is consistent with most studies at home and abroad, and proves that Chinese breast cancer patients have the same risk factors as foreign patients. However, the role of ER, PR and HER-2 expression is unclear, which may be related to the fact that some patients do not receive systemic endocrine and targeted therapy. More samples and multi-center prospective clinical studies are needed to confirm, but it still has certain clinical significance for the prognosis and intervention of breast cancer patients.
Ivosidenib off-label use for <i>IDH</i> mutant gliomas: The MD Anderson Cancer Center real life experience.
Authors: Keng Lam, Heather Y. Lin, Garret Williford, Chetna Wathoo, Nazanin Majd
Journal: Journal of Clinical Oncology (2023)

e14022 Background: Ivosidenib, a small-molecule IDH inhibitor is FDA approved for relapsed or refractory acute myeloid leukemia and cholangiocarcinoma with IDH1 mutation. Early phase clinical trials have shown promising findings for IDH mutant gliomas and results of larger studies of IDH inhibitors in gliomas are still pending. Meanwhile, neuro-oncologists continue to encounter patients with IDH mutant gliomas with limited treatment options. Here, we describe our experience with off-label use of ivosidenib in IDH mutant gliomas. Methods: This is a retrospective case series study in a single cancer care institute. Data points collected include but not limited to patient demographics, type of IDH mutation, treatment history prior to starting ivosidenib, duration of treatment, and progression-free survival. Descriptive statistics were used to summarize patient’s characteristics. The distribution of median progression-free survival (mPFS) was estimated by the Kaplan-Meier method. Results: From August 2018 to December 2022, we identified 13 patients with IDH-mutant glioma prescribed ivosidenib 500mg daily off-label. Four patients did not receive treatment: two were too sick soon after ivosidenib prescribed, and two were not able to get financial coverage. For the nine patients that were treated, median age was 37 (range 25-44). 8 were males and 1 was female. Five have IDH1 R132H mutations, 1p19q intact and four have IDH mutation and 1p19q co-deletion. The highest grade for the tumor is grade 3. Four have non-enhancing disease only. The median lines of therapy prior to starting ivosidenib was 2 (range 0-5). Three patients did not have radiation by the time they started ivosidenib, including two who received this drug as first-line treatment initiated by providers outside of MD Anderson. All patients are still alive as of January 11 th , 2023. Disease control rate (all stable disease) was 78%. After a median follow-up of 17.8 (range 15-29) months, mPFS was 3.81 (95% CI: 1.25, 12.78) months. Patients with non-enhancing disease had better PFS than those with enhancing disease, but this was not statistically significant (median PFS: 8.28 vs 3.81 months, p-value = 0.42). Two patients had adverse events: one with grade 1 lethargy, and another patient had a grade 3 surgical wound infection unrelated to the drug requiring a pause in treatment. Conclusions: Ivosidenib was successfully approved by third party payers for treatment of nine patients with IDH mutant gliomas. Ivosidenib was well-tolerated with a modest PFS. Patients with non-enhancing disease may trend toward better PFS than those with enhancing disease. The updated survival data and potential correlation with clinical, molecular, and radiographic data will be presented at the conference.
System-wide approach on biosimilars adoption in oncology: Strategic plan on switching and cost savings.
Authors: Suwicha Limvorasak, Kyung Kim, Crystal Leung Dobbs, Edwin Melencio Posadas, Kevin Scher, Johnny Chang, Vi Kien Chiu, Marcio A. Diniz, Andre Rogatko, Hilary Teaford, Leanne Sakamoto, Bruce Vinson, Vipul Patel, Robert A. Figlin, Rita Shane, Karen L. Reckamp
Journal: Journal of Clinical Oncology (2023)

1600 Background: Biosimilars provide competitive, lower-cost alternatives to biologic drugs in cancer treatment. As more agents become available in the US, institutions have to implement a strategy for successful adoption that is feasible, safe and provide price competition among biosimilar manufacturers. Methods: We aimed to standardize biosimilar utilization across the Cedars-Sinai Health System (CSHS) by integrating institutionally developed clinical pathways and insurance prior-authorization into the existing electronic health record (EHR). The initial study was limited to bevacizumab, rituximab and trastuzumab. To align with CSHS guideline recommendations, biosimilar indications for use were reviewed by each disease related group (DRG). Biosimilar brands for each drug were selected through a formulary process vetted by the Pharmacy &amp; Therapeutics Committee. Physicians were permitted to opt-out of switching via an option provided within the electronic order set. To test feasibility of this approach, patients were divided into two groups as 1) main medical center (Cedars Sinai Medical Center) and 2) Cedars-Sinai Cancer affiliated sites. Feasibility was defined as a compliance rate of 80% or greater at the main medical center and 75% or greater at the affiliated sites. This study was powered to detect a minimum difference at 5.7% and 8.9%, respectively. Results: Between January 2021 to September 2022, a total of 1,139 cancer patients who initiated treatment with bevacizumab, rituximab or trastuzumab were identified through the EHR, of whom 650 were eligible (age 18-96; 61% female, 39% male). Using our approach, the compliance rate was 86% at the main site (p&lt;0.001, 95%CI: 82.5-89.1) and 88% (p&lt;0.001, 95%CI: 82.1-91.7) at the affiliated sites, resulting in a 56% improvement from baseline (86% vs. 55%, p&lt;0.001). Among 14% of patients who did not switch to institutional-preferred biosimilar brands, the most common reasons for this were payer mandated use of an alternate brand (5%), off-label indication (4%), enrolled in patient assistance program (3%) and physician preference (2%). Five patients (&lt;1%) did not switch to biosimilars due to history of infusion reactions. Insurance type (HMO, PPO, Medicare, others) was not associated with non-compliance (p=0.876). Cost savings were projected to be over $4 million over a duration of two years. Conclusions: Enterprise-wide switching to one specific biosimilar brand is feasible and facilitated through leveraging of the EHR. This approach optimized exiting organizational infrastructure to standardize biosimilar utilization and promote substantial cost savings.[Table: see text]
Patient-reported usefulness of an intervention to promote job retention among women undergoing (neo)adjuvant breast cancer chemotherapy.
Authors: Victoria Susana Blinder, Jackie Finik, Sujata Patil, Bharat Narang, Maria Claros, Jennifer Suarez, Samantha Martinez, Monica Muppidi, Della F. Makower, Theresa Gillis, Ting-Ting Kuo, Francesca Gany
Journal: Journal of Clinical Oncology (2023)

1586 Background: Women who undergo (neo)adjuvant breast cancer chemotx are at risk of job loss, especially if they lack work accommodations. We developed TEAMWork (Talking to Employers And Medical staff about Work), an English/Spanish mobile application (app) to help women identify work accommodations relevant to their needs, negotiate with their employers to receive these accommodations, and communicate with the clinic team to manage symptoms. TEAMWork will be compared to a booklet as a job-retention tool in an ongoing randomized clinical trial (RCT). Here we present acceptability data based on RCT participants’ perceptions of the app’s usefulness. Methods: Eligible participants were women aged 18-64, who spoke English/Spanish, were able to use and had access to a smartphone/tablet, were undergoing or planned to undergo (neo)adjuvant chemotx for stage I-III breast cancer, and were working full or part time for pay. Women who had stopped working due to the diagnosis were eligible. Those who had stopped working for reasons unrelated to breast cancer (e.g., prior illness disability) were ineligible. Online surveys were self-administered or administered interview-style (per participant preference) at baseline and midway through the planned chemotx. In the second survey, participants were asked if they had used TEAMWork at all since enrollment; those who said they had used it were asked about the app’s usefulness. Results: 58 participants received the app; 56 received the booklet. 64% were white, 18% were Black, and 12% were Asian; 7% were Hispanic. 4% were Spanish-speaking. 79% had at least a college education. When surveyed half-way through their chemotx regimen, 62% of those randomized to the app said they had used the app; only 25% of those randomized to the booklet said they had used the booklet (p&lt;0.0001). Among those who reported having used the app (n=36), 86% said they were very (44%) or somewhat (42%) satisfied with TEAMWork, and 94% said they thought TEAMWork would be very (61%) or somewhat (33%) helpful to other patients. Additional details about the perceived usefulness of the app are shown. Conclusions: Compared to participants randomized to the booklet, more than twice as many who received the app reported that they had used their assigned intervention. Among those who used it, the app was well-received and was deemed especially helpful for communicating with medical providers. Recruitment to the RCT is ongoing, and job retention results will be presented when data are mature. Efforts are under way to increase the diversity of the study sample based on ethnicity, language, and education. Clinical trial information: NCT03572374 .[Table: see text]
Final prespecified overall survival (OS) analysis of CLEAR: 4-year follow-up of lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC).
Authors: Robert J. Motzer, Camillo Porta, Masatoshi Eto, Thomas Powles, Viktor Grünwald, Thomas E. Hutson, Boris Alekseev, Sun Young Rha, Jaime R. Merchan, Jeffrey C. Goh, Anil Kapoor, Ugo De Giorgi, Bohuslav Melichar, Sung-Hoo Hong, Howard Gurney, Karla Rodriguez-Lopez, Cixin S. He, Chinyere Okpara, Jodi McKenzie, Toni K. Choueiri
Journal: Journal of Clinical Oncology (2023)

4502 Background: In the phase 3 CLEAR trial, L+P showed clinically meaningful and statistically significant benefits in PFS (primary endpoint) and OS, and improved ORR compared with S in 1L aRCC (Motzer NEJM 2021). Here, we report 4-yr follow-up results from the final prespecified OS analysis of CLEAR (data cutoff: 31 Jul 2022). Methods: Treatment-naïve pts (n=1069) who had aRCC with a clear-cell component were randomized (1:1:1) to receive: L 20 mg PO QD + P 200 mg IV Q3W; or L 18 mg + everolimus 5 mg PO QD; or S 50 mg PO QD (4 wks on/2 wks off). Stratification factors were geographic region and MSKCC prognostic risk group. This final prespecified OS analysis was triggered by ~304 death events in 2 arms. OS, PFS, ORR, duration of response (DOR), and PFS on next-line therapy (PFS2) were assessed for L+P and S. PFS, ORR and DOR were assessed per independent review using RECIST v1.1. Nominal P-values are shown. Results: At a median follow-up (IQR) of 49.8 mos (41.4–53.1) for L+P and 49.4 mos (41.6–52.8) for S, 149 and 159 deaths had occurred, respectively. OS benefit with L+P vs S was maintained (HR, 95% CI; 0.79, 0.63–0.99). OS favored L+P vs S across MSKCC risk groups (HR, 95% CI; favorable [fav]: 0.89, 0.53–1.50; intermediate [int]: 0.81, 0.62–1.06; poor: 0.59, 0.31–1.12). PFS benefit of L+P vs S was maintained (HR, 95% CI; 0.47, 0.38–0.57). PFS favored L+P vs S across MSKCC risk groups (HR, 95% CI; fav: 0.46, 0.32–0.67; int: 0.51, 0.40–0.65; poor: 0.18, 0.08–0.42). ORR was greater with L+P (71.3%; complete response [CR], 18.3%) vs S (36.7%; CR, 4.8%) (relative risk, 95% CI; 1.94, 1.67–2.26). Less pts in the L+P arm (181/355, 51.0%) received subsequent anticancer therapies compared with the S arm (246/357, 68.9%); 56 (15.8%) and 195 (54.6%) received PD-1/PD-L1 checkpoint inhibitors, respectively. Analysis of OS adjusted for subsequent therapies will be presented. PFS2 was longer with L+P vs S (43.3 vs 25.9 mos; HR, 95% CI; 0.63, 0.51–0.77). Grade ≥3 treatment-related adverse events occurred in 74.1% and 60.3% pts in the L+P and S arms, respectively. Conclusions: L+P continues to demonstrate clinically meaningful benefit vs S in OS, PFS, ORR, and CR in the 1L treatment of pts with aRCC at 4-yr follow-up, thus supporting the robustness of the primary analysis data from CLEAR. Clinical trial information: NCT02811861 .[Table: see text]
Osemitamab in combination with capecitabine and oxaliplatin (CAPOX) as a first line treatment of advanced G/GEJ cancer: Updated data of cohort C from a phase I/IIa, multi-center study (TranStar102/TST001-1002).
Authors: Lin Shen, Dan Liu, Ning Li, Weijian Guo, Tianshu Liu, Hongli Li, Jiayi Li, Yuxian Bai, Yanhong Deng, Zhi-xiang Zhuang, Meili Sun, Qingxia Fan, Fuyou Zhao, Liang Han, Zhenzhong Xia, Jianming Wang, Charlie Qi, Li Xu, Xueming Qian, Caroline Germa
Journal: Journal of Clinical Oncology (2023)

4046 Background: Adding a claudin18.2 antibody to a chemotherapy is a clinically validated approach for patients with high CLDN18.2 expressing tumors. TST001 is a best in class differentiated antibody whose improved CLDN18.2 affinity and enhanced antibody-dependent cellular cytotoxicity, leads to anti-tumor activity in low to medium CLDN18.2 expressors gastric cancer cells. Pre-clinical studies also showed that TST001 has stronger tumor regression effects than the IMAB362-analog at the same dose. Methods: The efficacy and safety of osemitamab with CAPOX as 1st line treatment with G/GEJ cancer was explored in a dose escalation and expansion phase 1/2 study in China (Cohort C, NCT04495296). Positive claudin18.2 expression (membranous staining ≥1+ intensity in≥10% of tumor cells) as assessed centrally using the LDT assay was required in the expansion phase only. Results: As of Dec 31, 2022, 64 patients were dosed with osemitamab in combination with CAPOX, 15 patients received osemitamab at doses ranging from 1 to 8 mg/kg Q3W in the dose escalation and 49 patients at 6 mg/kg in the dose expansion. The median follow up was 151 days. Patient characteristics were typical of 1st line G/GEJ cancer, with relatively higher percentage of peritoneal disease (48.4%). Nausea (65.4%), vomiting (46.2%) and hypoalbuminemia (65.4%) were the most common adverse events related to TST001 at dose of 6mg/kg in 52 patients (3 patients in dose escalation and 49 patients in dose expansion), most of them were grade 1 or 2 (only one patient experienced grade 3 nausea and vomiting, and one experienced grade 3 hypoalbuminemia). In the expansion cohort, 40 of the 45 patients with measurable lesions had at least one post-treatment tumor assessment. 27 achieved partial response (PR) of which 21 were confirmed. There was no obvious trend in improved efficacy with higher level of CLDN18.2 expression based on overall response rate (ORR). Progression free survival (PFS) and duration of response (DOR) were still immature. Conclusions: TST001 in combination with CAPOX as first-line treatment for the patients with G/GEJ cancer is safe and encouraging anti-tumor activities have been observed regardless of the CLDN18.2 expression levels above 1+ intensity in &gt;=10% tumor cells per central LDT assay. Updated ORR, mPFS and mDOR will be presented at the time of the congress. Clinical trial information: NCT04495296 .
Meta-analyses of factors associated with long-term survival after resection of pancreatic ductal adenocarcinoma.
Authors: Asad Saulat Fatimi, Ammar Asrar Javed, Omar Mahmud, Alyssar Habib, Mahip Grewal, Jin He, Christopher Lee Wolfgang, Marc G. Besselink
Journal: Journal of Clinical Oncology (2023)

4165 Background: Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal malignancies. Long-term survival (&gt;5 years, LTS) is rarely seen even after ‘curative-intent’ resection. With improved systemic control via effective systemic therapies, LTS is now being reported more frequently. However, our understanding of LTS in PDAC remains limited. The aim of the current study was to perform a systematic review and meta-analysis to quantify the associations between various clinicopathological factors and LTS following resection of PDAC. Methods: The PubMed, Embase, Scopus, and Cochrane CENTRAL databases were systematically searched for articles reporting actual patient survival data. Two reviewers independently screened and reviewed articles, extracted relevant data, and assessed the risk of bias in included studies using the Newcastle-Ottawa scale (NOS). Data that compared patients who achieved LTS after resection with those who did not were extracted from the included studies. Meta-analyses using a random effects model were conducted to identify associations between LTS and various patient, tumor, and treatment related factors. Results: Overall, 33 studies with 46,981 patients after resection of PDAC were included. Most articles received a ‘good’ NOS assessment, indicating acceptable risk of bias. The median rate of LTS was 15.27% (IQR: 9.47-20.72). Multiple clinicopathological factors were found to be associated with LTS, including tumor grade (OR: 0.40, 95%CI: 0.31-0.52), tumor stage (OR: 0.36, 95%CI: 0.31-0.41), and margin status (OR: 0.43, 95%CI: 0.36-0.50). Factors that were not associated with LTS included patient age, tumor size, tumor location, or genetic mutations. Notably, adjuvant therapy (OR: 1.68, 95%CI: 1.24-2.28) but not neoadjuvant therapy (OR: 1.08, 95%CI: 0.62-1.87) were associated with LTS. Conclusions: This meta-analysis revealed that 15% of patients achieved LTS after resection of PDAC. Multiple clinicopathological factors are associated with LTS whereas presence of ‘traditional’ negative prognostic factors does not rule out LTS. Further studies are required to identify robust predictors of LTS in resected PDAC. [Table: see text]
Trends and characteristics of potentially preventable emergency department visits among patients with cancer in the US.
Authors: Amir Alishahi Tabriz, Kea Turner, Young-Rock Hong, Benjamin Daniel Powers, Jennifer Elston Lafata
Journal: Journal of Clinical Oncology (2023)

e13643 Background: An initial step to reducing emergency department (ED) visits among patients with cancer is to identify the characteristics of patients visiting the ED and examine which of those visits could be prevented. The objective of this study was to explore nationwide trends and characteristics of ED visits and examine factors associated with potentially preventable ED visits and unplanned hospitalizations among patients with cancer in the US. Methods: This cross-sectional study used data on ED visits from the National Hospital Ambulatory Medical Care Survey from January 1, 2012, to December 31, 2019; US Cancer Statistics reports were used to estimate new cancer cases each year. Frequencies and trends of ED visits by adult patients (aged ≥18 years) with cancer were calculated. The primary outcome was potentially preventable ED visits (using the Centers for Medicare &amp; Medicaid Services definition), and secondary outcomes were hospitalizations and the immediacy of the ED visits. Multivariable logistic regression analyses were performed to examine the associations of patient, hospital, and temporal factors with potentially preventable ED use and ED use resulting in hospitalization. Results: Among 854911106 ED visits, 35510014 (4.2%) were made by patients with cancer (mean [SD] age, 66.2 [16.2] years); of those, 55.2% of visits were among women, 73.2% were among non-Hispanic White individuals, 89.8% were among patients living in a private residence, and 54.3% were among Medicare enrollees. A total of 18 316 373 ED visits (51.6%) were identified as potentially preventable, and 5 770 571 visits (21.3%) were classified as high acuity. From 2012 to 2019, potentially preventable ED visits increased from 1 851 692 to 3 214 276. Pain (36.9%) was the most common reason for potentially preventable ED visits. The number of patients who visited an ED because of pain increased from 1 192 197 in 2012 to 2 405 849 in 2019 (a 101.8% increase). Overall, 28.9% of ED visits resulted in unplanned hospitalizations, which did not change significantly over time (from 32.2% in 2012 to 26.6% in 2019; P = .78 for trend). Factors such as residence in a nursing home (odds ratio, 1.73; 95% CI, 1.25-2.41) were positively associated with having a potentially preventable ED visit, and factors such as the presence of more than 1 comorbidity (odds ratio, 1.82; 95% CI, 1.43-2.32) were positively associated with having an unplanned hospitalization. Conclusions: In this study, 51.6% of ED visits among patients with cancer were identified as potentially preventable, and the absolute number of potentially preventable ED visits increased substantially between 2012 and 2019. These findings highlight the need for cancer care programs to implement evidence-based interventions to better manage cancer treatment complications, such as uncontrolled pain, in outpatient and ambulatory settings.